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510(k) Data Aggregation

    K Number
    K252518

    Validate with FDA (Live)

    Device Name
    DuoprossTM Smart Cap (Type I)
    Manufacturer
    Duopross Meditech Corporate
    Date Cleared
    2025-12-17

    (128 days)

    Product Code
    FMF
    Regulation Number
    880.5860
    Type
    Traditional
    Panel
    General Hospital
    Age Range
    All
    Reference & Predicate Devices
    K210818
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Smart Caps are indicated for use as sterile tip caps with tamper-evident function for luer-lock syringes. The use time of the Smart cap should be ≤ 24 hours.

    Device Description

    The Smart Cap is a tamper-evident syringe cap with a clear indication of cap removal to ensure sterility and reduce the risk of medical fluids being compromised accidentally or intentionally. Its assembly includes an outer cover, an inner cap and an inner ring. It is made of acrylonitrile butadiene styrene (ABS) and polypropylene (PP) and is sterilized by ethylene oxide.

    AI/ML Overview

    N/A

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